Received: 24 October 2016 | Revised: 26 December 2016 | Accepted: 4 February 2017

DOI 10.1111/cid.12482

ORIGINAL ARTICLE

Randomized controlled clinical trial comparing two dental

implants with different neck configurations

Ignacio Sanz-Martín, DDS, MS1 | Ignacio Sanz-S

anchez, DDS, DrOdont1 |
Fernando Noguerol, DDS, MS1 | Susy Cok, DDS, MS1 |
 n, DDS, MS1 | Mariano Sanz, MD, DDS, DrMed, DrHC1,2
Alberto Ortiz-Vigo

1
Section of Post-graduate Periodontology,
Faculty of Odontology, University
Abstract
Complutense of Madrid, Spain
Background: Peri-implant bone levels can vary according to the implant neck macro-design and
2
ETEP (Etiology and Therapy of Periodontal
the implant-abutment interface.
Diseases) Research Group, University
Complutense, Madrid, Spain Purpose: To compare the changes in soft and hard tissues when using a one-piece implant with a
Correspondence machined collar (TG) versus a two-piece implant with a progressive platform widening and a plat-
Mariano Sanz, Facultad de Odontología,
form switching connection (SP).
Universidad Complutense de Madrid, Plaza
Ramon y Cajal s/n. 28040, Madrid, Spain. Material and methods: Partially edentulous patients willing to receive one or two implants in the
Email: marsan@ucm.es
posterior maxilla or mandible were randomized to the control (TG) or to the test group (SP). Final
Funding information
prostheses were delivered after 12 months. Radiographic measurements of interproximal bone
Sweden & Martina SRL (Due Carrare,
Padova, Italy); University Complutense of levels (primary outcome) were assessed at implant loading and 1-year postloading. Clinical, patient
Madrid related outcomes and adverse events were assessed at loading and after 6 and 12 months.

Results: Sixty-one implants were placed in 47 patients, 37 patients (18 in the TG group and 19 in
the SP group), and 47 implants (23 TG and 24 SP) completed the 24-months follow up. At the
patient level, a significantly greater bone resorption from baseline to implant loading was observed
in the SP group (20.42 6 0.45 vs 20.07 6 0.45; P 5 .001*), while from loading to the final visit,
the TG group had significantly greater bone loss than the SP group (20.26 6 0.22 vs 20.11 6 0.2;
P 5 .020*). At 24 months after surgery, there were no significant differences between both groups
(control: 0.33 6 0.49 vs test: 0.53 6 0.53; P 5 .230). Similarly, no significant differences were
observed for the secondary outcomes.

Conclusions: Both types of implant reported high survival rates and similar bone level changes,
clinical parameters, and patient related outcomes after 12 months of loading.

KEYWORDS
controlled clinical trial, dental implants, machined collar, platform switching

1 | INTRODUCTION
Although dental implants have shown a high predictability and long-
1–4
term success, peri-implant diseases are becoming an increasing
problem that clinicians must learn to understand and prevent.5–7 These
diseases are characterized by a host inflammatory response to oral bac-
teria, including soft tissue inflammation with or without progressive
loss of supporting bone beyond biological bone remodeling.8 Different
implant designs, configurations, as well as surgical and prosthetic proto-
cols have been proposed with the aim of providing improved stability
in the peri-implant tissues.9 Among these, the implant neck configura-
tion and the implant-abutment connection have attracted interest due
to their possible influence in the preservation of the peri-implant hard
and soft tissues.9–11
In regards to their design, implants can be classified in one-piece
or two-piece. One-piece implants are comprised of an endosseous and
a transmucosal component, with the implant–prosthetic interface
located at increased distance from to the bone. This design has shown

Clin Implant Dent Relat Res. 2017;1–11 wileyonlinelibrary.com/journal/cid V

C 2017 Wiley Periodicals, Inc. | 1
2 | SANZ-MARTIN ET AL.

highly predictable results,12,13 including reduced bone loss and

decreased inflammation of the peri-implant tissues.14 This treatment
approach, however, may present aesthetic limitations, since the pol-
ished supracrestal component can show through the peri-implant soft
tissues or even be seen directly seen when placed supragingivally.15
In contrast, the two-piece implants consist of the implant being
placed fully endosseous with its shoulder at bone level. The second
piece (prosthetic components) are located transgingivally, thus allowing
improved emergence profiles and better aesthetic outcomes.16,17 These
implant design, however, may suffer some degree of marginal bone loss
at the time of abutment connection,18,19 what may expose the most
coronal aspect of the implant neck with a rougher micro-surface topog-
raphy, which may provide a higher risk of bacterial colonization.
With the goal of reducing this likely marginal bone loss seen
around two-piece implants at abutment connection, the concept of
platform switching (PS) was introduced.20,21 It is characterized by the
utilization of a smaller diameter prosthetic component connected to a
larger diameter implant platform.22 It is hypothesized that this inward FIGURE 1 Sweden & Martina implants. One-piece implant (TG);
shift in the perimeter of the implant-abutment junction would allow two-piece implant (SP)
the establishment of the biologic width more medially and thus mar-
ginal bone loss would be reduced.23,24  Fabrication of surgical guides from waxed-up models.
In spite of many scientific reports documenting these facts, there  Standardized intraoral photographs for registering the baseline site
is a lack of controlled randomized clinical trials comparing the use of status.
one-piece implants with a machined collar and a two-piece implants
with a progressive platform widening and a platform switching connec- Patients were selected based on the following criteria,
11
tion. It was, therefore, the aim of this study to assess whether a two-
2.2.1 | Inclusion criteria
piece implant with a platform-switching concept would result in
improved clinical, radiographic, and patient related outcomes when  Male or female 20-years old.
compared to a one-piece implant with a polished collar.
 Presence of one or more adjacent missing teeth in the posterior
maxilla or mandible (positions 4-7). A natural tooth had to be present
2 | MATERIALS AND METHODS mesially to the most proximal implant site, although free end situa-
tions were allowed.
2.1 | Study design
 Adequate bone quality and quantity at the implant site to allow the
The present study was designed as a randomized controlled clinical trial insertion of Sweden and Martina Premium TG and SP implants SLR
with a parallel group design. The proposed null hypothesis was that (Due Carrare, Padova, Italy), of diameters 3.8, 4.25, or 5 mm and
there would not be radiographic differences between the two-implant lengths between 7 and 13 mm (Figure 1).
designs. Following approval from the local ethical committee, selected
 Opposing dentition had to be natural teeth or implant supported
patients, previously screened for fulfilment of inclusion/exclusion crite-
fixed restorations.
ria, were asked to comply with the prescribed treatment and the
 Once informed on the follow-up visits, the patient had to be willing
follow-up visits, as well as for the collection of relevant study data.
to comply with the planned regimen.
When they agreed to participate by signing the approved informed
consent, they were then included in the study.
2.2.2 | Exclusion criteria
The exclusion criteria were divided in systemic, local and surgical fac-
2.2 | Subject population
tors. In addition to the general contraindication for dental implants the
Study patients were selected from those attending the Postgraduate following exclusion criteria were observed:
Clinic in Periodontics, School of Dentistry, University Complutense of
Madrid. The screening examination included the following: 2.2.3 | Systemic exclusion criteria

 Cone-beam CT to determine the bone availability for dental implants.  Medical conditions requiring prolonged use of steroids and/or with
 Clinical examination to evaluate the patient inclusion and exclusion medications that could interfere with bone metabolism.
criteria.  History of leukocyte dysfunction and deficiencies.
SANZ-MARTIN ET AL.
 History of neoplastic disease requiring the use of radiation or
chemotherapy.
 Patients with history of renal failure.
 Patients with metabolic bone disorders such as osteoporosis.
 History of uncontrolled endocrine disorders.
 Physical handicaps that would interfere with the ability to perform
adequate oral hygiene.
 Use of any investigational drug or device within the 30-day period
immediately prior to implant surgery on study day 0.
 Alcoholism or drug abuse.
 History of immunodeficiency syndromes.
 Patients who smoke >10 cigarettes per day or cigar equivalents.
 Conditions or circumstances, which in the opinion of the investiga-
tor, would avoid the completion of study participation, or interfere
with analysis of study results, such as history of noncompliance or
unreliability.
2.2.4 | Local exclusion criteria
 Untreated or active periodontitis defined as bleeding on probing
(BOP) with probing depths (PD) greater than 5 mm assessed by
means of a UNC-15 probe (Hu-Friedy. Chicago, IL)
 Mucosal diseases such as erosive lichen planus.
 History of local irradiation therapy.
 Inflammatory or developmental bone conditions that do not allow
the placement of dental implants in the regions of interest.
 Unhealed extraction sites (less than 6-weeks postextraction of teeth
in intended sites).
 Severe bruxism or clenching habits.
 Persistent intraoral infections such as active endodontic lessions,
peri-coronaritis, or untreated caries.
2.2.5 | Exclusion criteria at surgery
 Lack of primary stability defined as <10 Ncm measured by hand tor-
que wrench.
 Need of augmentation procedures in presence of dehiscences or
fenestrations >3 mm.
 Unable to place the implant according to the prosthetic
requirements.
Consecutive patients fulfilling the inclusion criteria following the
implant site preparation were randomized to receive either an implant
with a transgingival-machined collar of 2.2 mm (TG) or bone level
implants with a progressive widening platform (SP). One independent
investigator independent from those carrying out the screening per-
formed the randomization sequence using random block sizes that
were stratified according to tobacco. Allocation concealment was kept
using opaque-sealed envelopes, which were opened by 1 investigator
during surgery (immediately before the implant placement). In those
| 3
cases, where patients required implants in more than one quadrant, the
randomized quadrant was chosen by the following criteria: (1) quadrant
where no augmentation was performed, (2) quadrant where the higher
number of implants was needed, (3) quadrant number.
2.3 | Surgical procedures
Implant surgeries were performed under local anaesthesia by postgrad-
uate students under the guidance of experienced instructors. Muco-
periosteal flaps were raised by means of crestal incisions and implants
were inserted and placed either at bone level (SP) or at the limit of the
machined collar (TG). Mesiodistally, implants were placed at least 1.5–
2.0 mm from the adjacent natural tooth, and/or at a distance of
3.0 mm between two implants. Drilling was performed according to
manufacturers recommendation. The differences in the osteotomy
preparation lay in the use of the countersink bur, which was only used
in the SP group in order to allow the seating of the expanded implant
platform at the level of the osseous crest. In contrast, in the TG group
the treated surface was completely submerged allowing the transgingi-
val machined collar above the bone crest. Implant position was guided
by the restorative needs and was registered in the CRFs. Primary stabil-
ity was assessed by direct torque wrench testing. If implant dehiscence
or fenestrations <3 mm were encountered a xenograft bone substitute
(Sintlife 400-600 m, 0.5 g; Sweden and Martina, Due Carrare, Padova,
Italy) and a resorbable pericardium membrane (Bonetwo, Sweden and
Martina, Due Carrare, Padova, Italy) were used.
Patients were instructed to brush the treated area with a surgical
brush and to rinse twice a day with 0.15 mL of 0.12% Clorhexidine
(Perio-Aid tratamiento, Dentaid SL, Barcelona, Spain), for 60 seconds
until sutures were removed between 7 and 10 days postsurgery. Anti-
inflammatory drugs were also prescribed as required by the patient (Ibu-
profen 600 mg [CINFA S.A., Navarra, Spain], every 8 hours for 3 days).
2.4 | Restorative procedures
For both groups, healing caps were unscrewed and impressions were
taken at the implant level with either an open or closed tray impression
technique. Final prostheses were delivered 12 months after implant
placement and screw tightening was performed at a torque of 40 Ncm.
Digital standardized periapical radiographs and clinical measure-
ments were taken after definitive prosthesis installation. Finally, all
patients received oral hygiene instructions and a professional prophy-
laxis using Teflon-coated ultrasonic scaler tips.
2.5 | Outcome variables
Two calibrated examiners performed the clinical assessments
immediately after prosthesis installation and then 6 and 12 months
after. Similarly, standardized digital periapical radiographs were
taken after implant placement, after prosthesis installation and
then at 12 months postloading (Figure 2). For the measurements of
these main outcome variables, calibration of the examiners resulted
in inter and intraexaminers reliability with more than 85% of
agreement.
4 |
FIGURE 2 Example of clinical cases: radiographic evaluation
Each visit also included the evaluation of any change in the
patients dental or general history as well as patient’s reported out-
comes. All patient complaints or the advent of any complication, such
as pain, paraesthesia, or peri-implant infection were recorded.
2.5.1 | Radiographic assessment
Changes in interproximal bone levels were recorded by measuring the
distance from the implant shoulder to the first visible bone to implant
contact (DIB: distance of implant to first bone contact) at the mesial
and distal aspect of each implant. The standardization of the radio-
graphs was achieved using a parallel technique with the aid of Rinn-
Holders and individual silicon bite registrations. Two calibrated exam-
iners executed all the measurements by means of computer image
analysis software (Image J. National Institutes of Health [NIH],
Bethesda, MD). Inter and Intraexaminer reliability was assessed by
means of a calibrating session were 20 random radiographs were meas-
ured twice by both examiners (kappa values >0.8). The elimination of
image distortions and the determination of the exact magnification
were achieved by calibrating all images using the known distance
between two implant threads and the length of the implants. For the
TG implant 2.2 mm were subtracted from the linear measurement, cor-
responding to the machined collar.
2.5.2 | Clinical and aesthetic assessments
Clinical measurements were assessed on six sites per implant, using a
manual periodontal probe (PCP UNC-15, Hu Friedy, Chicago, IL). The
following parameters were registered: PD, keratinized tissue amount
on the mid-buccal and mid-palatal/lingual sites, plaque index (PI) (6),
BOP (6), and mobility of the implant.
SANZ-MARTIN ET AL.
Changes in soft tissue margins around implants and adjacent teeth
were evaluated using a manual periodontal probe (PCP UNC-15, Hu
Friedy, Chicago, IL) and registered with standardized photographs. The
clinical crown length of the adjacent tooth (CLT: distance in mm from
the occlusal aspect to the most apical site of the mucosal curvature)
and the clinical crown length of the implant-supported crown (CLI: dis-
tance from the occlusal aspect of the implant prosthesis to the most
apical site of the mucosal curvature) were recorded.
The Pink Esthetic Score25 was used to assess the aesthetic out-
come using seven parameters independently: mesial papilla, distal
papilla, marginal tissue level, soft tissue contour, alveolar process, soft
tissue color, and soft tissue texture.
2.5.3 | Patient reported outcomes measures
PROMS were assessed by means of a questionnaire comprising of five
items: comfort, appearance, masticatory function, taste, and overall sat-
isfaction. Patients were asked to rate these five aspects according to
the following scale: very unsatisfied, unsatisfied, fair, satisfied, and very
satisfied.
2.5.4 | Adverse events
The adverse events were classified as “implant or prosthesis related” or
“non-implant related.”. In regards to the first one, this included biologi-
cal (ie, bone fracture, loss of osseointegration, chronic pain, and peri-
implantitis as defined by the 7th European Workshop in Periodontol-
ogy26) and mechanical complications (ie, fracture of devices such as
crown or abutment, etc). As for the second one, this group included
death or any life-threatening condition.
SANZ-MARTIN ET AL. | 5

FIGURE 3 Study sample flow-chart

2.6 | Statistical analysis All data was analyzed at the subject level and one implant per
patient was randomly chosen as test implant for the implant level anal-
A sample size calculation was performed to establish the minimum sub-
ysis. The interproximal bone level changes were considered the main
jects included in the study. The criteria for significance was established
outcome measurement. As for this, the mean distance of the mesial
as 5% for the type I error and 20% for the type II error. Taking into
and distal aspect was taken into consideration. For this outcome, the
consideration a mean difference in bone levels of 0.20 mm with a
data was analyzed at the implant and subject level.
standard deviation (SD) of 0.15727 and assuming a 20% of likely drop-
The statistical analysis was assessed with the aid of the software:
outs, a minimum of 44 subjects (22 per group) with a minimum of 44
SPSS V 21.0.0 (SPSS Inc., Chicago, IL).
implants were required.
Data normality was assessed using the Shapiro–Wilk Test and
intra/intergroup comparisons were assessed using ANOVA. Chi-square
3 | RESULTS
test was assessed for the distribution of categorical variables such as
3.1 | Study population and follow up
gender; medication, tobacco, and implant position, while Mann–Whit-
ney test was used for the crestal bone level changes. A two-sided value Figure 3 reflects the flowchart of the study population. Patient recruit-
of P  .05 was considered to be statistical significant. ment was conducted from January 2013 to July 2013. Forty-eight
6 | SANZ-MARTIN ET AL.

TA BL E 1 Baseline demographic characteristics of the study sample

Treatment group
Total (n 5 47) TG (Control, n 5 25) SP (Test, n 5 22) P-value

Sex (n and % subjects)

Male 21 44.68% 14 66.67% 7 33.33% .100
Female 26 55.32% 11 42.31% 15 57.69%

Age (mean and SD) 57.72(11.9) 59.73(10.549) .540

Smoking (n and %) .560

Nonsmoker 36 76.60% 18 72.00% 18 81.81%
Former smoker 1 2.12% 1 4.00% 0 0.00%
Smoker <10 cigs/day 10 21.28% 6 24.00% 4 18.18%

ASA classification (n and %) .487

Type I 26 55.32% 13 52.00% 13 59.10%
Type II 21 44.68% 12 48.00% 9 41.90%

Number of implants placed 33 28 .680

Single units 33 70.21% 17 68.00% 16 72.72%
Multiple units 14 29.79% 8 32.00% 6 27.28%

Implants position .870

Maxilla 30 49.18% 17 51.52% 13 46.42%
Mandible 31 50.82% 16 48.48% 15 53.58%

Implants position .820

Premolars 26 42.62% 14 42.42% 12 42.85%
Molars 35 57.38% 19 57.58% 16 57.15%

Implant diameter .750

3.8 mm 19 31.15% 12 36.36% 7 25.00%
4.25 mm 24 39.34% 11 33.33% 13 46.43%
5 mm 18 29.51% 10 30.30% 8 28.57%

Implant length .210

7 mm 6 9.84% 2 06.06% 4 14.28%
8.5 mm 20 32.79% 8 24.24% 12 42.86%
10 mm 21 34.43% 12 36.36 9 32.14%
11.5 mm 11 18.03% 9 27.27% 2 07.14%
13 mm 3 4.92% 2 06.06% 1 03.58%

TG, transgingival; SP, switching platform; n, number of subjects or implants; SD, standard deviation; cigs, cigarettes.

patients were enrolled; nonetheless, one patient was excluded within the
surgery due to lack of primary stability. A total of 47 patients and 61
implants were included in the study. One patient was excluded due to
early bone loss before loading and one patient was lost because the pros-
thesis was delivered at 4 months after surgery. At 6 months postloading,
one patient experienced a prosthetic abutment fracture, the implant had
to be removed since the abutment could not be extracted. At 12 months,
two patients experienced peri-implantitis and 5 patients did not show up
for this visit (three refused to continue in the study and two were not
able to continue due to medical conditions). The overall survival rate was
98.4% (100% in the TG group and 96.4% in the SP group).
3.2 | Demographic data and general health status
The sample included 21 (44.7%) men and 26 (55.3%) women with a
mean age in the TG group of 57.7 and in the SP group 59.7. 55.3% of
the subjects were systemically healthy and were classified as ASA type I
patients, whereas 44.7% were classified as ASA type II due to the use of
regular medication. The majority of the recruited patients (78%) had a
previous history of periodontitis, but there were no differences between
test and control groups. Furthermore, 10 patients (21.3%) reported
being current smokers, 1 (2.1%) was a former smoker, and 36 (76.6%)
had never smoked. There were no statistical significant differences
between the groups at baseline in any of these variables (Table 1).
3.3 | Interventions
Twenty-five subjects (53.2%) and 33 implants were randomized to the
control group (TG) and 22 (46.8%) subjects and 28 implants to the test
group (SP). In the TG group, a total of 14 (42.4%) implants were placed
in the premolar area and 19 (57.6%) on the molar area. In the SP group,
a total of 12 (42.9%) implants were placed on the premolar area and
16 (57.1%) on the molar sites. Moreover, 30 (49.2%) implants were
located in the maxilla and 31 (50.8%) in the mandible. Seventeen
screw-retained single crown restorations were delivered in the TG
group and 16 in the SP group, while 8 and 6 screw-retained implant
SANZ-MARTIN ET AL. | 7

TA BL E 2 Radiographic variables 0.2 mm) in the SP group. This difference was statistically significant
(P 5 .02) (Table 2).
TG group SP group
Implant level Mean SD Mean SD P-value
3.5 | Clinical and aesthetic assessments
DIB (mm)
Loading 0.11 0.45 0.44 0.45 .003* 3.5.1 | Probing depth
12 months 0.39 0.53 0.56 0.51 .23
There were no statistically significant differences in probing depth at
DIB changes (mm) 20.27 0.24 20.12 0.19 .01* loading, 6 months and 12 months within or between groups. In the TG
L - 12 m
and SP groups, the mean PD at loading was 2.94 mm (SD 1.05 mm)
Patient level
and 2.95 mm (SD 0.62 mm), respectively. At 12 months, these meas-
DIB (mm) ures were slightly increased to 3.17 mm (SD 0.70 mm) in the TG group
Loading 0.07 0.45 0.42 0.45 .001* and remained in 2.95 mm (SD 0.7 mm) in the SP group (Table 3).
12 months 0.33 0.49 0.53 0.53 .23

DIB changes (mm) 20.26 0.22 20.11 0.2 .02* 3.5.2 | Plaque index
L - 12 m
Both groups have a slight increment in the percentage of plaque. In the
DIB, distance implant shoulder—first bone to implant contact; SD, stand- TG group, the percentage of positive sites increased from 17.61% to
ard deviation; L, loading; *, statistically significant differences between
27.7% at 12 months and in the SP group from 22% to 27.16%. How-
groups (P  .05).
ever, there were not statistically significant differences within or

supported fixed partial dentures were delivered, respectively. With between groups (Table 3).

regards to the implant distribution, most of the implants presented a

3.5.3 | Bleeding on probing
diameter of 3.8 mm and a length of 10 mm in the TG group and a
The percentage of positive sites in the control group increased from
diameter of 4.25 mm and length of 8.5 mm in the SP group (Table 1).
26.83% to 34.22%, at 12 months. In contrast, in the test group, these
values were reduced from 25.37% to 23.26%. However, these
3.4 | Radiographic assessment (DIB)
differences were not statistically significant within or between groups
3.4.1 | Implant-level analysis (Table 3).
The implant level analysis included a total of 47 implants (22 TG and 25
TA BL E 3 Mean values for the different clinical outcomes
SP). In the TG group, the mean distances between the reference point
and the marginal bone level was 20.11 mm (SD 0.45 mm) at loading TG group SP group
and 20.39 mm (SD 0.53 mm) after 12 months. The corresponding val- P-value
Mean SD Mean SD inter
ues for the SP group were 20.44 mm (SD 0.45 mm) at loading, and
20.56mm (0.51 mm) 12 months later. The difference between the TG PD (mm) Loading 2.94 1.05 2.95 0.62 .756
and the SP group at loading was statistically significant (P 5 .003). 6 months 3.17 0.70 3.05 0.78
12 months 3.17 0.70 2.95 0.70
In regards to the change of the bone level between loading and 12 P-value intra .719 .768
months, the TG group experienced higher marginal bone loss, exhibit-
PI (%) Loading 17.61 17.52 22.00 30.90 .714
ing a mean of 20.27 mm (SD 0.24 mm) lost compared to 20.12 mm
6 months 24.06 24.90 26.37 33.00
(SD 0.19 mm) in the SP group. This difference was statistically signifi- 12 months 27.70 25.00 27.16 33.43
cant (P 5 .01) (Table 2). P-value intra .341 .824

BOP (%) Loading 26.83 19.00 25.37 23.16 .570

3.4.2 | Patient-level analysis
6 months 26.89 24.90 31.58 34.60
In the patient level analysis, one implant was randomly selected in 12 months 34.22 25.21 23.26 26.80
cases of multiple unit restorations, corresponding to 18 implants in the P-value intra .392 .659

TG group and 19 in the SP group. KM (mm) Loading 4.78 0.94 4.05 1.43 .221
The results were very similar at this level. In the TG group, the 6 months 4.50 2.09 4.05 1.31
12 months 4.17 1.33 3.84 1.53
mean distances between the reference point and the marginal bone
P-value intra .104 .502
level was 20.07 mm (SD 0.45 mm) at loading and 20.33 mm (SD
0.49 mm) after 12 months. The corresponding values for the SP group CLI (mm) Loading 8.72 1.40 8.58 1.98 .891
6 months 9.28 1.48 9.37 2.00
were 20.42 mm (SD 0.45 mm) at loading, and 20.53 mm (0.53 mm)
12 months 8.72 1.48 9.00 2.08
12 months later. The differences between the TG and the SP group at P-value intra .021* .105
loading were statistically significant (P 5 .001).
TG, transgingival; SP, switching platform; PD, pocket depth; PI, plaque
In regards to the change of the bone level between loading and 12 index; BOP, bleeding on probing; KM, keratinized mucosa width; CLI,
months; the TG group experienced higher marginal bone loss, exhibit- crown length of the implant; SD, standard deviation; *, statistically signif-
ing a mean of 20.26 mm (SD 0.22) lost compared to 20.11 mm (SD icant (P  .05).
8 |
FIGURE 4 Patient related outcome measurements at 12 months
(PROM’s)
3.5.4 | Keratinized mucosa
There was a slight reduction of keratinized tissue from loading to 6 and
to 12 months in both treatment groups, but these differences were not
statistically significant for any of the comparisons (Table 3).
3.5.5 | Soft tissue margin
From baseline to 6 months, there was a slight increase in the CLI that
was significant only in the TG group (from 8.72 to 9.28 mm in the TG
group and from 8.58 to 9.37 mm in SP group). At the end of the study,
there was a slight coronal displacement of the gingival margin in both
groups, although no statistically significant differences between groups
were found at any time point (Table 3). For the adjacent teeth, both
the mesial and distal experienced a slight recession (<0.75 mm) and no
differences were seen between groups.
3.5.6 | Pink esthetics score
The pink esthetics includes seven items and these parameters were
evaluated separately. Most of the changes were found in the mesial
and distal papilla, followed by the marginal tissue level. As for this last
one, both groups experienced a slight worsening of the tissues. Fur-
thermore, the soft tissue contour, the alveolar process, and the color
seemed to remain more stable overtime in both groups. No SS differ-
ences were found between groups (Appendix Table A1).
3.5.7 | Patient reported outcomes measurements
Patients from both treatment groups showed a high degree of satisfac-
tion with the treatment (Figure 4). No patient reported to be unsatis-
SANZ-MARTIN ET AL.
fied or very unsatisfied at any parameter. In general, the taste was the
best-rated item and the appearance the least. However, there were no
statistically significant differences between groups for any of the items
evaluated.
3.5.8 | Technical complications
At 6 months postloading, one patient in the SP group experienced a
prosthetic abutment fracture from one of the implants supporting a
short-span bridge, which was not possible to remove. Three patients
from the SP group presented crown mobility due to screw loosening at
the 12 month follow up. In this situation, the screws were retightening
and patients were recalled to check for the stability of the prosthesis.
4 | DISCUSSION
A high implant survival rate was found for both implant designs 24
months after placement (12 months after loading). The SP group expe-
rienced significantly higher marginal bone loss between placement and
loading at both implant and patient levels when compared to the TG
group (0.44 vs 0.11 mm at implant level). Between loading and 12
months, both the SP and TG groups experienced minor further crestal
bone level changes (20.12 and 20.27 mm at implant level, respec-
tively). In the TG group, most of the bone level change occurred
between loading and 1 year postloading while in the SG group most of
the change occurred between implant placement and loading.
These observed crestal bone level changes are consistent with
those reported in other clinical investigations using a similar
design.28–30 The comparison of one-piece versus two-piece standard
implants using a split mouth study design did not find significant differ-
ences on changes in marginal bone levels, either at 1-year postload-
ing28 or at 3 years.29 Similarly, using a parallel design RCT comparing
one and two-piece implants, no significant differences were found at
12 months after loading.30
Different from the pervious reports, in this investigation we eval-
uated as test implants, two-piece implants with a platform switched
connection. The use of this design has shown minimal bone loss over
time in other clinical trials.10,31,32 A recently published systematic
review revealed significant reductions in crestal bone loss when plat-
form switched implants were compared to regular platform implants
(20.41 mm 95% CI 20.52 to 20.29)33 and long-term follow-up have
also reported minimal bone loss over time.34 The results reported in
this study, however, have shown that one-piece implants were signifi-
cantly superior in preventing crestal bone level changes between
implant placement and loading when compared with the platform
switched bone-level implants. This different behavior during implant
healing may be explained by different factors:
First the demonstrated stability of the one-piece implant design,
which has been widely reported in the literature and has demonstrated
stable marginal bone levels 1 year after loading (0.1 mm)28 5 years after
loading (0.32 mm)35 and 10 years after loading (0.86 mm)36 Experimen-
tal studies comparing one versus two piece implants explained the
higher early (before loading) bone loss of the two piece implants by the
SANZ-MARTIN ET AL.
presence of a microgap at the implant to abutment connection37–39
which was amenable for contamination, followed by inflammation, and
marginal bone loss.40 These differences in the bone level changes
between placement and loading may also be explained by the conse-
quences of abutment dis/reconnection. A recent RCT has shown that
the connection and disconnection of the abutments (one dis/reconnec-
tion) led to greater bone loss when compared with the direct place-
41
ment of definitive abutments at implant placement. It can be
hypothesized that the prosthetic maneuvers performed in the two-
piece implants may have influenced bone levels more significantly, as
the implant to abutment connection was closer to the bone.
Other factors that may explain the differences could be the differ-
ent drilling protocols and differences in the final position of the implant
in relation to the bone crest. SP implants needed additional burs to
expand the coronal implant platform and thus allow a correct seating of
the implant shoulder at the level of the bone crest. The submerged wide
platform may have exerted excessive loading on the peri-implant bone,
42
specially in cortical bone, leading to greater early bone loss. Although
the surgical protocol was aimed to place the SP implants leveled with
the crestal bone and the TG implants leveled at the line separating the
polished metal collar from the rough titanium, in situations of uneven
residual ridges the metal polished collar in TG implants or the SP implant
shoulder may have been submerged in order to avoid the exposure of
rough titanium. The impact of the subcrestal position of these different
implant designs may also have induced different crestal bone resorption
patterns. In both implant designs, the subcrestal position may lead to
43
greater bone loss, although in PS implants the subcrestal position
(1 mm) may prevent the exposure of rough titanium surface.44
In the present study, although both implant designs maintained
crestal bone levels between loading and 1-year, TG implants demon-
strated a significantly higher bone level change. These differences,
however, although statistically significant, were of small magnitude
(20.12 and 20.27 mm) and probably irrelevant clinically. Although the
implant to abutment connection is at a distance from the bone in TG
implants and therefore, a higher mechanical stress under loading is
expected with this implant design when compared to one-piece
implants,45 the possibility that this higher biomechanical load may be
translated in more bone loss is unlikely. A more plausible explanation
may be due to differences in plaque and bleeding scores between both
groups once the definitive prosthesis were installed. The TG group pre-
sented slightly higher plaque levels and greater BOP, although these
differences were not statistically significant.
With regards to soft tissue changes, both implant designs showed a
slight decrease in the amount of keratinized mucosa (KM), although there
were no differences between the two systems. In both treatment groups,
the CLI seemed to increase at 6 months going back to baseline levels at
12 months. The minimal changes in crown height observed are consistent
with those reported in a study with a similar methodology that compared
46
one-piece and two-piece implants at one year of loading.
At the end of the study, the plaque and bleeding scores reported
were considered relatively high despite the efforts in motivating the
patients on the importance of an adequate oral hygiene between the
| 9
recall visits. This may have had an impact in the incidence of biological
complications. The incidence of peri-implantitis was 4.25%, which is
considered relatively high although smaller than what has been
reported in a recent systematic review.7 Nevertheless, the linear corre-
lation existent between the years of loading and the incidence of the
disease should be taken into account.
A possible explanation to the undesirable events may be that the
population consisted mainly of patients with a history of periodontitis.
These patients may exhibit significantly greater long-term probing
pocket depth, peri-implant marginal bone loss, and incidence of peri-
implantitis when compared with periodontally healthy subjects.47,48
Moreover, plaque levels increased over the study period, which may
have increased the risk for disease onset.49
The higher rate of technical complications seen in the SP group, in the
form of abutment fracture and screw loosening, may be explained by the
differences seen in the connection of the two systems used. While both
had an internal hexagon, the TG implants had an additional 208 conical
cone that may have provided increased stability and, therefore, resulted in
fewer complications. Most of the available literature has focused on com-
paring the behavior of internal versus external connections.50 Since there
is no evidence comparing prosthetic complications of different implant
designs, such as those used in this study, it is difficult to confirm or refute
previous hypothesis. In vitro investigations have observed that conical
connections provided greater resistance to deformation and fracture51
and lower stress to the prosthesis and abutment complex.52,53
Although there was a high number of dropouts and patients lost
during the study follow-up, the power of the study was not affected
since additional number of patients and implants were included fore-
seeing this event. This fact may be due to the late delivery time of the
final prosthesis, 12 months after implant surgery.
5 | CONCLUSION
Within the limitations of this study, it can be concluded that both
implant designs resulted in high survival rates and similar bone level
changes, clinical parameters, and patient related outcomes 12 months
after loading (24 months after implant placement). The control implant
design (TG), however, resulted in lesser marginal bone level changes
during the healing phase before implant loading. This different behavior
may not have consequences on the stability of peri-implant hard and
soft tissues, but this fact, however, needs to be elucidated with future
clinical research including longer-term evaluation times.
ACKNOWLEDG MENTS
The authors would like to thank Dr María Minguez and Dr Juan Bol-
laín for their contributions in the clinical handling of the study
patients during this investigation.
CONFLICTS OF INTERES T
The authors declare to have no conflict of interests with the materi-
als used in the present study.
10 | SANZ-MARTIN
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TG, transgingival; SP, switching platform; P, P-value.